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This research aims to gather long-term safety and effectiveness information for people treated with ibrutinib, a medicine taken by mouth that blocks a specific enzyme called brutons tyrosine kinase. The study focuses on participants who previously took part in ibrutinib studies that have finished and are still receiving ibrutinib treatment, continuing to benefit from it. It is an open-label study, meaning both participants and researchers know the treatment being given. Participants will continue taking ibrutinib capsules daily at the dose they were given in their prior study until the doctor decides the treatment is no longer helpful due to disease progression or side effects, the participant chooses to stop, other treatment options become available, or the study ends. Safety will be monitored throughout, and effectiveness data may be combined with previous study results. No formal testing of hypotheses is planned in this extension. During the study, participants will be regularly monitored for safety and disease status. The main outcome is the number of participants experiencing side effects within 30 days after the last ibrutinib dose or before starting another cancer therapy. Participants may continue treatment until alternative access to ibrutinib is arranged or the study ends, which is planned for December 2029. Researchers will collect ongoing data to understand the long-term effects of ibrutinib treatment.

Researchers are evaluating the effects of a parenteral vitamin B12 combination treatment versus an oral vitamin B12 monotherapy on vitamin B12 status in adults with vitamin B12 deficiency. The study aims to compare changes in serum vitamin B12 concentration after 4 weeks of treatment, along with other markers such as holotranscobalamin, homocysteine, methylmalonic acid, and quality of life measures. Safety and tolerability of both treatments are also being assessed in this Phase 4 trial sponsored by Medice Arzneimittel Ptter GmbH & Co KG. Participants are randomly assigned to receive either the vitamin injection or oral vitamin B12 tablets. The injection group receives 1 intramuscular injection twice weekly at the clinical site, totaling 8 injections over 4 weeks. The oral group takes one tablet daily in the morning for 28 days. The vitamin injection contains a fixed combination of vitamin B6, B12, and folic acid, while the oral treatment consists of vitamin B12 tablets. During the study, participants undergo assessments of various blood markers at baseline, day 28, and follow-up at day 56. These include vitamin B12, holotranscobalamin, homocysteine, methylmalonic acid, combined vitamin B12 markers, and serum levels of related compounds. Quality of life is evaluated using questionnaires such as WHO-5, SF-36, and VAS EQ-5D. Safety and tolerability are monitored throughout. The total participation duration includes a 4-week treatment period followed by a safety follow-up at day 56.

This research aims to assess the physical impact of Multiple Sclerosis MS from the participants perspective. It also provides participants continued access to the medication ocrelizumab while evaluating its safety and tolerability. The study is an open-label extension phase 3 trial sponsored by Hoffmann-La Roche, focusing on patients previously enrolled in related studies who currently lack local access to ocrelizumab treatment. Participants will receive ocrelizumab either as a 600 mg intravenous infusion or a 920 mg subcutaneous injection, following the dosing schedule established in their prior parent study. Treatment will continue until local access to the drug becomes available, if safety concerns arise, if the participant withdraws consent, or in the event of death. During the study, participants will be monitored for changes in physical functioning using patient-reported outcome measures over up to five years. Researchers will also track the number of participants receiving ocrelizumab and monitor adverse events, including serious or special interest events that may lead to discontinuation. Safety and tolerability assessments will continue throughout the study duration, which may last up to five years.

Researchers are evaluating sodium zirconium cyclosilicate SZC to treat hyperkalaemia in children under 18 years old. This Phase 3, international, open-label study aims to assess the effectiveness, safety, and tolerability of SZC. The study enrolls about 140 children from multiple countries, starting with age groups 6 to under 12 years and 12 to under 18 years. Later, younger age groups may be included based on data reviews. The goal is to see how well SZC controls potassium levels in children with this condition. The study includes three treatment phases Correction Phase CP, Maintenance Phase MP, and Long-Term Maintenance Phase LTMP. In the CP, participants receive fixed doses of SZC orally three times daily for up to 3 days until potassium levels normalize. Doses are adjusted based on body weight and age groups, with possible dose increases after safety reviews. Those who achieve normal potassium enter the 28-day MP with once daily SZC, where doses can be adjusted to maintain potassium levels. Participants may continue in the LTMP using the same dosing approach with monthly visits. Participants undergo regular monitoring including blood tests, urine tests, and ECGs to assess potassium levels, electrolytes, and heart rhythm. Researchers track safety, tolerability, potassium control, and other biochemical changes throughout the phases. The study lasts about 28 weeks, including treatment and a safety follow-up visit one week after the last dose. Data collected will help evaluate SZCs role in managing hyperkalaemia in children.

Researchers are investigating the outcomes for mothers diagnosed with cancer during pregnancy, focusing on overall survival and the long-term development of children exposed to cancer or cancer treatments before birth. The study aims to understand how prenatal exposure to therapies like chemotherapy, radiation, or targeted treatments may affect childrens neurological and heart health as they grow. The study includes several parts initially, it registers and tracks maternal and neonatal health during pregnancy and delivery, including collecting blood samples and tissue biopsies. Emotional needs of parents facing a cancer diagnosis are assessed through questionnaires. The second part follows children exposed in utero to cancer treatments with regular check-ups at various ages up to adulthood, including neurological and cardiological exams, and optional MRI sessions. Participants will undergo scheduled assessments including blood sample collection, placental biopsies, and questionnaires for parents. Children will have neurological and heart evaluations at set ages from 6 months through 18 years, with further cardiologic monitoring every five years into adulthood. The research team monitors overall survival in mothers and developmental outcomes in children, ensuring comprehensive long-term follow-up extending potentially into the fourth decade of life for offspring.

Researchers are evaluating the efficacy and safety of cariprazine in treating schizophrenia among adolescents aged 13 to 17 years. This international, multicenter study is designed as a randomized, double-blind, placebo-controlled trial to understand how cariprazine affects symptoms of schizophrenia in this younger population. Participants will be randomly assigned to receive either cariprazine capsules at doses of 1.5 mg or 4.5 mg once daily, or matching placebo capsules once daily. The treatment phase lasts for six weeks, during which participants take the assigned capsules orally every day. During the study, participants will be monitored regularly to assess changes in their schizophrenia symptoms using the Positive and Negative Syndrome Scale PANSS. Researchers will also evaluate safety and tolerability throughout the trial. The main measurement is the change in PANSS total score from the start to the end of the six-week period. The study is designed to last until December 2026.

Researchers are evaluating the effectiveness and safety of masitinib combined with riluzole compared to a placebo combined with riluzole for treating Amyotrophic Lateral Sclerosis ALS. This phase 3 study focuses on patients diagnosed with probable or definite ALS, aiming to understand how masitinib, a drug that targets cells involved in neuroinflammation, might slow disease progression and affect the nervous systems environment. Participants receive oral masitinib at 3.0 mgkgday twice daily, with dose increases to 4.5 mgkgday after 4 weeks, and for some, an additional increase to 6.0 mgkgday after another 4 weeks. Each dose increase includes safety monitoring. Masitinib is given alongside riluzole, a standard ALS treatment at 50 mg twice daily. The control group receives a matching placebo with riluzole. The study is randomized, double-blind, and includes two different masitinib dose escalation schedules. During the 48-week study period, participants undergo regular assessments including functional rating scales ALSFRS-R, quality of life questionnaires ALSAQ-40, survival and progression monitoring, lung function tests FVC, and muscle strength measurements HHD. Researchers measure changes in combined function and survival scores. Safety is closely monitored throughout, with follow-up extending up to 36 months for disease progression or death. Total participation includes baseline screening, treatment, and long-term observation.

This research aims to collect real-world data on the characteristics, management, healthcare use, and outcomes of patients living with type 2 diabetes, hypertension, heart failure, and chronic kidney disease. It is an international observational registry that includes patients from many countries to better understand how these conditions are treated in everyday clinical practice. Participants in this registry are observed without receiving experimental treatments. Data are collected both retrospectively and prospectively using a cloud-based electronic case report form accessible to investigators and a scientific committee. The registry includes groups of patients with type 2 diabetes, hypertension, chronic kidney disease, or heart failure, either as their primary condition or as a coexisting condition. Patients provide information about their health status, treatments, and outcomes over time. Researchers collect data on demographics, disease characteristics, laboratory tests, treatments, healthcare visits, hospitalizations, and lifestyle factors. The study measures many outcomes such as blood sugar levels, kidney function, heart function, medication use, and health events over an average of three years. Participation is voluntary and ongoing, with data collection continuing until the study end date in 2030.

This research evaluates the long-term safety and effectiveness of pembrolizumab in participants with advanced tumors or hematologic malignancies who have previously taken part in Merck pembrolizumab-based studies. This phase 3 extension study includes participants currently on treatment or in follow-up from parent trials. The study has three phases based on participants prior treatment status First Course Phase, Survival Follow-up Phase, and Second Course Phase, allowing continuation or observation depending on prior participation. Participants receive pembrolizumab alone or combined with other treatments such as standard of care therapies, lenvatinib, olaparib, MK-4280, MK-4280A, or pembrolizumab with berahyaluronidase alfa. Dosing schedules vary by phase and regimen, including intravenous infusions of pembrolizumab every 3 or 6 weeks, oral lenvatinib capsules daily, oral olaparib tablets twice daily, and other biologics administered intravenously or subcutaneously. The study allows up to 35 doses in the First Course Phase and fewer doses in the Second Course Phase, with treatment durations adjusted for crossover eligibility and combination therapies. Participants are monitored through regular treatment visits involving drug administration and follow-up assessments. Researchers evaluate overall survival up to approximately 10 years, along with progression-free survival, event-free survival, and adverse events including serious and clinically significant side effects. The study includes ongoing safety monitoring up to around 40 months post-treatment. Participants remain under observation for long-term outcomes and potential treatment effects for many years after enrollment.

Researchers are studying the safety and tolerability of low motoneuron stimulation using high-frequency repetitive transcranial magnetic stimulation HF-rTMS in people with spinal muscular atrophy SMA. SMA is a condition where muscle weakness occurs due to nerve problems, and exercise may help prevent muscle loss. However, regular exercise can be difficult for people with SMA due to physical and psychological challenges. This trial explores whether HF-rTMS can mimic exercise effects on muscles, especially for those who cannot perform physical activities easily. Participants will receive HF-rTMS targeting the primary motor cortex of the limbs at a frequency above 5 Hz and intensity of 90-100% of their resting motor threshold. The treatment involves up to 10 sessions, each delivering up to 2400 stimuli. Additionally, cerebrospinal fluid will be collected via lumbar puncture before and after the treatment to measure specific proteins related to SMA. During the study, participants will undergo assessments of motor function using several scales and tests, including the Motor Function Measure Scale, the Revised Upper Limb Module, the Hammersmith Functional Motor Scale - Expanded, and the 6-Minute Walk Test. These will be performed before the first TMS session and shortly after the last session. The study evaluates changes in motor abilities and monitors safety and tolerability throughout the trial, which runs until January 2026.